The External Quality Audit (single user digital version)

Dec 2001
PDA Item Number
PDF Single user
Member Price
Nonmember Price
Government Price

The companion to The Internal Quality Audit, this book performs the same valuable function by helping you focus on issues specific to your suppliers, contractors, and consultants. External audits help you ensure that each supplier consistently provides valuable services that enhance your efficacy and your bottom line. This book shows you how to effectively evaluate suppliers to determine their reliability and capability of keeping a supply of quality product, whether goods or services, flowing through your process and on to your customer.

Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file - 4.51 MB)

Table of Contents

Table of Contents:

1. The First Step

  • Deciding to Audit
  • Staffing the External Auditing
  • Setting the Tone
  • Determining Audit Roles
  • Focusing on Areas Prime for External Audit Attention
  • Setting Workable Time Frames for Conducting Audits
  • Completing Initial Audit Activities
  • Preparing the Tools
  • Conducting the Physical Audit
  • Reporting and Assessing
  • Maintaining an External Audit Schedule
  • Making Audits a Way of Life
    2. The Homework
  • Establishing the Scope of the Audit
  • Determining the Depth of the Audit
  • Selecting the Audit Team
  • Determining the Binding Regulations
  • Reviewing the Previous Audits Reports and Records
  • Identifying Necessary Documents
  • Assessing the Supplier's Culture
  • Scheduling the Audit
  • Making the Preliminary Contacts
  • Putting It In Writing
  • Receiving and Reviewing Documents
    3. The Measurements And Tools
  • Understanding Measurements
  • Charting the Course: The Audit Plan
  • Preparing Checklists
  • Confirming the Audit
  • Keeping Notebooks
    4. The Audit
  • The Opening Meeting
  • Reviewing Documents On-Site
  • Auditing a System or Process
  • Interviewing the Players
  • Posing Open-Ended Questions
  • Listening Actively
  • Reading Non-Verbal Communication Signals
  • Observing the Activities
  • Identifying Nonconformances
  • Looking at Related Systems for Disconnects
  • Auditing Batch Records, Device History Files,
  • or Other Documentation
  • Hitting Records Page by Page
  • Exchanging Information During the Audit
  • Preparing for the Closeout
  • The Closeout Meeting
    5. The Evaluation And Report
  • Compiling the Audit Observations
  • Remaining Unbiased
  • Preparing the Report
  • Writing Guidelines
  • Formatting the Reports
  • Cover Sheet or Page Header
  • Presenting the Report In-House
  • Forwarding the Supplier's Report
    6. The Next Step
  • Evaluating Responses
  • The Spirit of the Findings
  • Seeking Clarification
  • Offering Confirmation
  • When the Audit Results are Poor
  • Closing the Loop
  • Conducting Follow-Up Audit
  • Archiving Records
  • Establishing an Audit Schedule
  • Making Audits an Integral Part of Operations
  • A Final Note
    7. References
  • About the Authors

    About the Authors:

    Monica Grimaldi is a senior auditor with pharmaceutical and medical device experience. A chemist with a background in quality control and method development, she now conducts internal and external quality audits internationally for a major healthcare company. She is also an ISO Certified Lead Auditor.

    Janet Gough is the director of technical communications for Cerus Corporation, a biotech company. Her background includes consulting to the pharmaceutical industry and teaching technical writing and English as a Second Language (ESL) at the university level. She is the author of "Write It Down: Guidance for Preparing Effective and Compliant Documentation, Second Edition".